Your quality system
A QMS assessed every day. A surveillance audit without surprises.
MAC reads your procedures and records, checks them against ISO 13485 and the MDR and IVDR, and tells you what to fix before your notified body sees it.
Example · Quality system- FTraining record not signed
- DPurchasing procedure contradicts the supplier qualification plan
- CReference to a withdrawn work instruction
- AManagement review complete and up to date
What MAC does for your QMS
The groundwork, done continuously.
Continuous assessment of procedures and records
MAC assesses your QMS requirement by requirement, against ISO 13485 and the MDR and IVDR. It also checks the records filled in by other departments, where errors most often slip in. Every grade is backed by exact quotes from your documents.
Consistency across your documents
A revised procedure that contradicts an old protocol, a reference to a document that no longer exists: MAC checks your documents against each other and flags what no longer holds.
Assisted internal audit
Planning, checklists built on the facts in your documentation, a drafted report. The internal audit becomes a moment of improvement again rather than an administrative chore.
Responses to audit nonconformities
Upload your notified body's report: MAC finds the evidence that already exists in your documents and drafts the responses, root cause and impact included. When evidence is truly missing, it tells you what to produce.
See the use caseAn action plan for every gap
Every gap becomes a prioritised action, with the content to insert in the document concerned. Tasks are deduplicated and tracked on a shared board, with an approval workflow.
Several sites, one view
Running several entities or subsidiaries? MAC brings the compliance of all your quality systems into the same interface, with a score per site.
The nonconformities raised during the audit had all been identified by the tool beforehand. No surprises on the day.
Services
Would you rather we did it for you?
Our experts deliver the service, with the platform as their engine. You pay for the outcome, not the hours.
The other areas
One tool to keep everything compliant.
Your questions, answered.
Does MAC replace our eQMS?
No. MAC is not an eQMS: it connects to your tools (eQMS, document management, SharePoint or Google Drive) and assesses what is in them. Your processes and tools stay the same.
Our QMS is still being built. Is MAC useful?
Yes. MAC assesses what already exists and tells you what is missing, requirement by requirement. You move forward in order, without forgetting a document, all the way to certification.
What happens to our internal audit?
It stays yours. MAC prepares the checklist from your documentation and drafts the report; the auditor runs the interviews and keeps the judgement.
Do MAC's analyses count as evidence?
They are for information. Every finding quotes the relevant passage of the document, so your team can check and decide.
See your QMS assessed by MAC.
30 minutes with our team: you connect your documentation and see the first results on your own quality system.